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Evaluation and Treatment of Iron Deficiency in Ovarian Cancer Patients

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ClinicalTrials.gov Identifier: NCT03933813
Recruitment Status : Recruiting
First Posted : May 1, 2019
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
This study tests the hypothesis that IV iron sucrose infusions given to iron deficient ovarian cancer patients prior to debulking surgery can improve pre-operative iron stores and decrease transfusion of packed red blood cells in the peri-operative period. 21 participants at least 18 years of age with epithelial ovarian cancer of any stage requiring neoadjuvant chemotherapy and surgery will be enrolled. Participants will be on study for a period of up to 3 months.

Condition or disease Intervention/treatment Phase
Epithelial Ovarian Cancer Anemia Iron Deficiency Anemia Other: Iron Sucrose Phase 1 Phase 2

Detailed Description:

Iron deficiency and anemia are common in cancer patients. Data from the University of Wisconsin (UW) suggest that more than 50% of ovarian cancer patients undergo blood transfusion during their cancer treatments. Transfusion rates are particularly high in patients who receive neoadjuvant chemotherapy (NACT), despite multiple opportunities to diagnose and treat anemia prior to surgery. Blood transfusions have been associated with worse survival in ovarian cancer patients. Seventy-seven percent of ovarian cancer patients who receive NACT at the UW are anemic prior to surgery, and the same percentage receive a perioperative blood transfusion, defined as a blood transfusion within 72 hours of surgery. Iron deficiency without anemia is also common in cancer patients, though little has been published regarding how frequently it occurs in ovarian cancer patients. Functional iron deficiency, a lack of iron incorporation into erythroid precursors despite adequate iron stores, is also common in cancer patients. Study investigators hypothesize that IV iron sucrose infusions given to iron deficient ovarian cancer patients prior to debulking surgery can improve pre-operative iron stores and decrease transfusion of packed red blood cells in the peri-operative period.

Eligible participants will have a new epithelial ovarian cancer diagnosis, with planned neoadjuvant chemotherapy and interval debulking surgery. The study cohort will consist of participants with iron deficiency without anemia (defined below) prior to starting chemotherapy. Iron deficient participants with anemia are already offered iron sucrose infusions as part of their standard of care treatment.

The study group will include participants with planned neoadjuvant chemotherapy and debulking surgery with a normal Hgb within 30 days of study enrollment. Iron studies including ferritin, transferrin, total iron binding capacity (TIBC), reticulocyte count and serum iron, will be performed on these participants for research purposes only. Consent will be obtained prior to drawing research-related iron studies. The majority of participants will have Hgb levels available in their records from the last 30 days, either from the UW, or from a referring institution. If this is not the case, pre-chemotherapy lab studies will be obtained the day of their visit, which would routinely include a Hgb level.

Participants will sign a consent to receive four IV iron sucrose transfusions, prior to their debulking surgery, and be followed for prospective data collection. Consent will be signed for the infusion and for prospective data collection related to future laboratory studies and rates of transfusion of blood products. Participants with a normal Hgb and normal iron studies will participate in the prospective data collection portion of this study only. Prospective data collection will continue until subjects have completed first-line chemotherapy.

Subjects will be enrolled until 21 evaluable participants have been enrolled. Evaluable participants will have true or functional iron deficiency without anemia and have received at least one IV iron sucrose infusion.

Iron studies will be repeated 21 days (+/- 7 days) after last infusion in participants who receive IV iron sucrose. Participants with persistent iron deficiency will be referred to hematology.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Unblinded, window of opportunity trial
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation and Treatment of Iron Deficiency in Ovarian Cancer Patients Receiving Neoadjuvant Chemotherapy
Estimated Study Start Date : July 15, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020


Arm Intervention/treatment
Experimental: IV Iron Sucrose
Four intravenous iron sucrose infusions prior to debulking surgery administered as four 200mg infusions, given no less than 7 days apart over a 30 day +/- 7 day period
Other: Iron Sucrose
Venofer (Iron Sucrose Injection USP) is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use.
Other Name: Venofer




Primary Outcome Measures :
  1. Rate of Peri-operative Blood Transfusion [ Time Frame: Within 72 hours of surgery, up to 5 weeks on study ]
    Defined as a transfusion of Packed Red Blood Cells (PRBCs) within 72 hours of surgery, in iron deficient ovarian cancer patients who receive IV iron sucrose therapy prior to surgery compared to a historical controls (historically 77%). The primary endpoint will be summarized with descriptive statistics and conducted using a Fisher's exact test and exact binomial confidence intervals. Point estimates and exact 95% confidence intervals (CI) will be calculated.


Secondary Outcome Measures :
  1. Rate of Iron Deficiency Anemia [ Time Frame: up to 21 days following surgery ]
    The rate of iron deficiency anemia in all ovarian cancers patients at the University of Wisconsin. This endpoint will be summarized with descriptive statistics and conducted using a Fisher's exact test and exact binomial confidence intervals. In particular, point estimates and exact 95% confidence intervals (CI) will be calculated.

  2. Rate of Resolution of Iron Deficiency Anemia After Intervention [ Time Frame: up to 21 days following surgery ]

    Iron deficiency anemia is defined as ferritin > 30 ng/mL and iron saturation of < 50%.

    This endpoint will be summarized with descriptive statistics and conducted using a Fisher's exact test and exact binomial confidence intervals. In particular, point estimates and exact 95% confidence intervals (CI) will be calculated.


  3. Incidence of Treatment Emergent Adverse Events (AEs) [ Time Frame: up to 21 days following surgery ]

    Safety and Tolerability will be monitored by measuring adverse events data with date of onset (or worsening) on or after the start-date treatment with iron sucrose and end of study (post-operative visit (7 to 21 days following surgery). AEs are defined as mild, moderate and severe.

    This endpoint will be summarized with descriptive statistics and conducted using a Fisher's exact test and exact binomial confidence intervals. In particular, point estimates and exact 95% confidence intervals (CI) will be calculated.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provide written informed consent.
  • Has a diagnosis of true or functional iron deficiency without anemia within 30 days of treatment on this protocol

    • Iron deficiency without anemia (normal Hgb >/= 11.6 g/dL but ferritin < 30 ng/mL)
    • Functional iron deficiency without anemia (ferritin >30 ng/ml and iron saturation of <50%)
  • Has a clinical diagnosis of suspected epithelial ovarian cancer based on imaging studies, exam findings and laboratory values
  • Participants must be planning to receive neoadjuvant chemotherapy for their cancer diagnosis (NACT is defined as chemotherapy prior to debulking surgery)
  • Participants must be planning to undergo surgery for their cancer diagnosis
  • Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to administration of first dose of IV iron sucrose. WOCBP is defined as patients who retain their reproductive structures and are not menopausal (defined as > age 50 with no menses for at least 1 year)
  • Participants of reproductive potential must agree to use effective birth control during study participation. Effective birth control is defined as any FDA approved contraceptive method

Exclusion Criteria:

  • Currently taken any form of oral or intravenous iron therapy. Patients must have discontinued iron therapy > 30 days from study entry
  • Current untreated or unstable heart disease
  • History of iron induced hypersensitivity or allergy
  • History of leukemia, lymphoma, or other myelodysplastic disorders
  • Prior diagnosis of hemochromatosis or hemoglobinopathy (e.g. thalassemia)
  • Any subject with immediate requirement for radiotherapy
  • Concomitant enrollment in another clinical trial interfering with endpoints on this study
  • Any medical condition which could compromise participation in the study according to the investigator's assessment
  • Female patient who is pregnant or breast-feeding
  • Patients unwilling or unable to comply with the protocol or unable to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03933813


Contacts
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Contact: Cancer Connect 800-622-8922 skotila@wisc.edu

Locations
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United States, Wisconsin
University of Wisconsin Carbone Cancer Center Recruiting
Madison, Wisconsin, United States, 53792
Principal Investigator: Lisa Barroilhet, MD         
Sub-Investigator: Joseph Connor, MD         
Sub-Investigator: Moniba Nazeef, MD         
Sub-Investigator: Janelle Sobecki-Rausch, MD         
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Lisa Barroilhet, MD University of Wisconsin, Madison

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03933813     History of Changes
Other Study ID Numbers: UW18106
2019-0022 ( Other Identifier: Institutional Review Board )
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Wisconsin, Madison:
ovarian cancer
anemia
iron deficiency
blood transfusion

Additional relevant MeSH terms:
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Trace Elements
Micronutrients
Anemia
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Anemia, Iron-Deficiency
Hematologic Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Iron
Ferric Oxide, Saccharated
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics